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This study is designed to compare two different surfaces of bone anchored hearing aid abutments in terms of bacterial colonization, inflammatory response and skin reactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oticon Medical Machined Abutment | Sham Comparator | A non surface modified abutment is used |
|
| Oticon Medical Modified Abutment | Experimental | A surface modified abutment is used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone anchored hearing aid | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of colony forming units (CFU) | The primary end point is CFU counts 3 months post-surgery. | 3 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of colony forming units (CFU) on abutment (CFU/abutment) | 3 months post-surgery | |
| Number of colony forming units (CFU) on abutment (CFU/abutment) | 12 months post-surgery | |
| Measure | Description | Time Frame |
|---|---|---|
| Skin status according to Holgers and clinical assessment | 3 months post surgery | |
| Skin status according to Holgers and clinical assessment | Up to 24 months post surgery | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sofia Jonhede | Sponsor GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otorhinolaryngology, Karolinska University Hospital | Stockholm | 171 76 | Sweden |
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| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Number of colony forming units (CFU), strip (CFU/strip) |
| 3 months post-surgery |
| Number of colony forming units (CFU), strip (CFU/strip) | 12 months post-surgery |
| Number of colony forming units (CFU) in tissue samples (CFU/mg | 3 months post-surgery |
| Number of colony forming units (CFU) in tissue samples (CFU/mg | 12 months post-surgery |
| RNA level for host inflammatory response | 3 months post-surgery |
| RNA level for tissue repair | 3 months post-surgery |
| RNA level for host host microbial infection response | 3 months post-surgery |
| RNA level for host inflammatory response | 12 months post-surgery |
| RNA level for tissue repair | 12 months post-surgery |
| RNA level for host host microbial infection response | 12 months post-surgery |
| Histology investigation of tissue biopsy | 3 months post-surgery |
| Histology investigation of tissue biopsy | 12 months post-surgery |
| Postoperative complications |
| 3 months post surgery |
| Pain and numbness | Up to 24 months post surgery |
| Implant stability by clinical assessment and implant stability quotient (ISQ)measurements | Up to 24 months post surgery |
| Pocket depth | 6 months post surgery |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |